What's New? (2008)
At a glance...
This page highlights some of the most recent updates to IRB/ORI policy, procedures, and guidelines.
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In order to receive electronic issues of the IRB Review Newsletter, or to receive a hard copy of past issues, contact the Office of Research Integrity at 859-257-9428 or e-mail cdmay1@email.uky.edu and provide your name, e-mail address, department, campus address and phone number.
- 7/28/08: IRB Review Newsletter [PDF]
- UK Regional Human Research Protection Conference
- Unanticipated Problem/Adverse Events (UP/AE) involving prisoners
- 6/16/08: The Office of Research Integrity developed a guidance document for enrolling K-12 students as research subjects, particularly when conducting research into teaching methods, curricula and other areas related to the scholarship of teaching and learning. The guidance promotes methods to reduce risk of undue influence and outlines the necessary steps for obtaining facility approvals; requirements for parental permission, student assent or consent waivers; applicable privacy regulations and other protections for consideration when conducting research in this population. Investigators should refer to this guidance when submitting protocols that will enroll K-12 students: "Guidance for Enrolling K-12 Students as Research Subjects" [PDF].
- 6/9/08: The following addition was made to the Informed Consent SOP per recommendations from the Association for the Accreditation of Human Research Protection Programs (AAHRPP):
When the long form of consent documentation is used, the VA investigator enters a progress note in the subject’s medical record documenting when the subject’s participation is terminated. This is in addition to the VA progress note requirements already outlined in the SOP, for when the "Written Consent Document (Short Form)" is utilized. See the Informed Consent SOP [HTML] for detailed progress note requirements applicable to Veterans Affairs Medical Center research studies.
- 5/23/08: IRB Review Newsletter [PDF]
- New Form B
- International Ethics Resources Available
- Report of the Public Responsibility in Medicine Research (PRIM&R) Human Tissue/Specimen Banking Working Group
- 5/21/08: Four Standard Operating Procedures (SOP) were revised and put into production (Initial Full Review; Continuation Review; Generation, Use, & Revisions of SOPs; Mandated Reporting to External Agencies), and a section pertaining to research involving prisoners was added to the first page of the instructions in the Unanticipated Problem/Adverse Events Internal Prompt Reporting Form [WORD] [RTF].
- 5/18/08: Based on recommendations in the final report by the AAHRPP Council, the Informed Consent Process section of the Research Description (Medical "Form B" and Nonmedical "Form B") was revised to include a request for a description of other written materials that may be provided to participants or legally authorized representatives. Researchers should be sure to replace any previously saved versions of "Form B" with the one provided in the online IRB application.
- 4/7/08: Three revised documents were posted to ORI's Educational Materials, Regulations and Policy Guidance web page. Two documents entitled "Summary FDA Requirements For Investigators Who Are Also Considered Sponsors of New Drug" [PDF] and "Summary Of FDA Requirements For Investigators Who Are Also Considered Sponsors of New Devices" [PDF] are under the topic heading Investigational New Drugs/Devices. One document entitled "Sponsor-Investigator Clinical Trials with FDA Regulated Products" [PDF] is under the topic heading Investigator Responsibilities. The "Determination of Activities That Need IRB Review SOP" [WORD] [PDF] was also revised and posted to ORI's Standard Operating Procedures web page.
- 4/7/08: The availability of the IRB Survival Handbook as an easy to navigate indexed web-manual was announced. Contents of the IRB Survival Handbook focus primarily on UK policies and procedures for human research review, and the IRB application process. The A-Z indexed manual provides one-click access to topics from Adverse Events to VA Research. The Survival Handbook is located at http://www.research.uky.edu/ori/IRB-Survival-Handbook.html. Book copies of the handbook are still available upon request but the web-based version allows for real-time updates and access to the latest guidance and information.
- 3/1/08: Effective immediately, the ORI/IRB requires a complete list of study personnel to be submitted: 1) at Continuation Review (CR) time (regardless of whether a change is being requested), and 2) upon submission of a Modification Request (MR) if the request involves a change to study personnel.
The SP list should include designation of responsibilities including who is authorized to obtain informed consent and whether the individual listed has completed the mandatory human research protections training. To ensure all pertinent information is included, it is strongly recommended that the IRB/ORI Study Personnel List Template [WORD] [RTF] be utilized (alternately, the SP List found at the end of “Form A”/General Information Sheet of the IRB application can also be used as it is the same format). For more details, see the February 2008 "Study Personnel List Requirement" listserv announcement: [PDF].